Viral Respiratory Tract InfectionWE SENSENCT05290792
Use of Wearable Sensors for Early Detection and Tracking of Viral Respiratory Tract Infections
A study testing Administration of FluMist (Live Attenuated Influenza Vaccine) in people with Viral Respiratory Tract Infection and Influenza, run by Emily McDonald at 1 site in Canada.
Trial summary
Viral respiratory tract infections (VRTI) are among the most common human illnesses, impacting billions globally. There is an unmet need to identify novel ways to detect, treat and prevent their spread. New wearable devices could address this need, using special biosensors worn by patients. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Viral Respiratory Tract Infection, Influenza
- What is being tested?
- Administration of FluMist (Live Attenuated Influenza Vaccine)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- 10 Dec 2021to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men or women aged 18-59 years
- Did not receive the 2021-2022 seasonal influenza vaccine
- Not planning to get another vaccine during the 14-day observation period.
Who cannot join
- PCR-confirmed VRTI at screening
- Any infectious symptoms (fever, cough, rhinorrhea, sore throat, diarrhea, loss of smell or taste) within the previous 7 days
- Any chronic medical condition;
- Obesity (BMI>35 kg/m2);
- Any prescription drug other than oral contraceptives or routine and stable dose medications;
- Contraindication to LAIV
Show all 13Show fewer
- Current smoker or ex-smoker with >20 pack years of smoking
- Recreational drug use
- Self-reported history of substance abuse
- Pregnant or attempting to become pregnant
- Guillain-Barré syndrome (GBS) or BGS-like episode has occurred within 6 weeks of any prior influenza vaccination
- Immunocompromised
- People with severe asthma or medically attended wheezing in the 7 days prior to the proposed date of vaccination.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Innovative Medicine - McGill University Health Centre
Montreal, Quebec, H4A 3J1
About this study
Official title: Use of Wearable Sensors for Early Detection and Tracking of Viral Respiratory Tract Infections: The WE SENSE Study
Viral respiratory tract infections (VRTI) are among the most common human illnesses, impacting billions globally. There is an unmet need to identify novel ways to detect, treat and prevent their spread. New wearable devices could address this need, using special biosensors worn by patients.
This is a single centre, controlled, before and after, longitudinal, clinical trial. Participants will receive FluMist, a live attenuated influenza vaccine, which will act as a proxy to a viral respiratory tract infection and create a very minor response to the immune system. Vital signs and activity levels will be monitored continuously using wearable biosensors for 7 days prior to and 7 days following, along with symptom tracking and blood tests to measure immune responses. Artificial intelligence (AI) and machine learning (ML) algorithms will be used to analyse the data.
Read more
AI and ML will identify subtle changes in vital signs and activity levels from the immune response to respiratory viruses. These data will help develop future methods to address important public health questions related to respiratory virus detection, containment and management.
The purpose of this study is to explore whether wearable sensors can detect, track the progress and recovery from viral respiratory tract infection.
Read the detailed description
Presently, there are no tools to continuously assess the objective body's response to respiratory viral infection in real time. An individual's inflammatory response to infection is primarily measured by the presence of symptoms. For example, reliance on the presence of fever as a sensitive sign of viral infection, while objective and measurable, can miss at least 50% of symptomatic cases of influenza illness. Fever is also not a sufficient sign of infection in studies of SARS-CoV-2. An additional technology to pair with the present contact tracing, test and contain strategy could become a critical public health mitigation strategy for VRTIs. Evidence suggests that use of wearable biosensor technology may enable researchers and healthcare professionals to detect inflammatory responses. Therefore, they could assist in medical diagnosis at the early phase of disease development - even before the onset of clinical symptoms.
In this study, the investigators aim to leverage FLUMIST, an intranasal Live Attenuated Influenza Vaccine (LAIV), to create a very minor response of the immune system. FLUMIST is one of the vaccines recommended by the National Advisory Committee on Immunization (NACI), among other vaccines for this flu season. It will be used as a test case, representing body's response to a minor viral infection (like those of 'common cold'). In addition, the associated changes in vital signs (for example, changes in heart rate), activity levels, symptoms and inflammatory/immune markers will be monitored. Subtle patterns of change might only be detectable using artificial intelligence (AI). Applying AI and machine learning (ML) to the wearables' data can allow for the future early detection of VRTI, along with continuous tracking of its progress, recovery or deterioration.
Study schedule:
Patient participation in this research project will last 2 weeks and will include 14 visits. Each visit will last up to 60 minutes. During this 14-day follow-up period, participants will be required to wear 3 vital signs monitoring systems (shirt, watch and a ring) and to report twice daily about their wellbeing/symptoms and about their alcohol/caffeine/drugs consumption.
Assessments:
-VRTI detection: To rule out asymptomatic VRTI during the baseline (pre-LAIV) period, a nasopharyngeal 21-multiplex polymerase chain reaction (PCR) test, which includes influenza, SARS-CoV-2 and other respiratory viruses, will be performed at screening. For those eligible participants that enter the study, baseline assessments will start the morning of Day -7 and be performed 7 days before inoculation (Days -7 to 0), which will occur the morning of Day 0.
-Symptom assessment: The following symptoms will be assessed through an app-based survey sent to participants twice daily during the 14-day observation period: nasal discharge; nasal obstruction; sneezing; headache; sore throat; malaise; muscle ache; cough; chilliness; decreased appetite; stomach ache; vomiting; diarrhea; shortness of breath; and wheeze. Symptom severity will be graded as 0 (absent) to 7 (severe).
-Wearable vital sign monitoring systems: Three wearable smart platforms will be used for continuous monitoring of physiologic and activity parameters using biosensors: Oura ring (Oura Oy, Finland); Biobeat watch (Biobeat technologies LTD, Israel); and Astroskin shirt (by Hexoskin, Canada).
-Inflammatory cytokines and biomarkers: A venous blood sample for measurement of inflammatory cytokines and biomarkers will be obtained by a healthcare professional once in the morning of Day -7 (baseline sample 1) and then twice daily starting Day 0, with baseline sample #2 collected prior to inoculation on Day 0.
-Physiological response assessment: Participants will complete five, 3-minute constant-rate stair stepping tests (3-min CRSST). The 3-min CRSST requires participants to step up and down a 20cm step to the pace of a constant external audio beep. Participants will complete all trials at a 30 steps/min stepping rate. Cardiac and respiratory parameters will be collected at rest and during each 3-min CRSST using the wearable devices.
- Conditions
- Viral Respiratory Tract Infection, Influenza
- Being tested
- Administration of FluMist (Live Attenuated Influenza Vaccine)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of FluMist (Live Attenuated Influenza Vaccine)Biological
Participants will received the intranasal FluMist vaccine that will serve as a proxy for a viral respiratory tract infection and trigger a mild immune response.
| Study group | Role | What they receive |
|---|---|---|
| Intra-individual changes of physiological and activity parameters | Other | Participants will be administered FluMist (live attenuated influenza vaccine) to induce a low grade VRTI (Day 0). Participants will be monitored in the 7 days prior and 7 days after vaccination via symptom questionnaires, blood draws, stair tests and vital sign monitoring from wearable sensors.
Each participant will serve as their own control, relying on the baseline measurements obtained over the 7-day period prior to inoculation. Receives: Biological: Administration of FluMist (Live Attenuated Influenza Vaccine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in heart rate (in beats per minute)
Intra-individual changes in heart rate before and after receipt of the Live Attenuated Influenza Vaccine measured by wearable sensors.
Measured: 14 days
Changes in heart rate variability (in milliseconds)
Intra-individual changes in heart rate variability before and after receipt of the Live Attenuated Influenza Vaccine measured by wearable sensors.
Measured: 14 days
Changes in respiratory rate (in breaths per minute)
Intra-individual changes in respiratory rate before and after receipt of the Live Attenuated Influenza Vaccine measured by wearable sensors.
Measured: 14 days
Changes in skin temperature (in degrees Celsius)
Intra-individual changes in skin temperature before and after receipt of the Live Attenuated Influenza Vaccine measured by wearable sensors.
Measured: 14 days
Changes in acceleration (meters/second^2)
Intra-individual changes in acceleration before and after receipt of the Live Attenuated Influenza Vaccine measured by wearable sensors.
Measured: 14 days
Changes in blood pressure (in mmHg)
Intra-individual changes in blood pressure before and after receipt of the Live Attenuated Influenza Vaccine measured by wearable sensors.
Measured: 14 days
Changes in oxygen saturation (SpO2 in %)
Intra-individual changes in oxygen saturation before and after receipt of the Live Attenuated Influenza Vaccine measured by wearable sensors.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start10 Dec 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Viral Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single centre, controlled, before and after, longitudinal, intra-individual assessment
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emily McDonald
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Université de Montréal
- Responsible party
- Sponsor-investigator, Emily McDonald, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Emily G McDonald, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreDennis Jensen, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290792
- Sponsor's protocol ID
- 2022-7591
- Acronym
- WE SENSE
- Status last verified
- Oct 2023
- First submitted
- 25 Feb 2022
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified data and code may be available for educational or research purposes upon reasonable request to the Principal Investigator, Dr. Dennis Jensen (dennis.jensen@mcgill.ca), subject to inter-institutional data sharing agreements
Publications
Molinari NA, Ortega-Sanchez IR, Messonnier ML, Thompson WW, Wortley PM, Weintraub E, Bridges CB. The annual impact of seasonal influenza in the US: measuring disease burden and costs. Vaccine. 2007 Jun 28;25(27):5086-96. doi: 10.1016/j.vaccine.2007.03.046. Epub 2007 Apr 20.
PubMed 17544181Schanzer DL, McGeer A, Morris K. Statistical estimates of respiratory admissions attributable to seasonal and pandemic influenza for Canada. Influenza Other Respir Viruses. 2013 Sep;7(5):799-808. doi: 10.1111/irv.12011. Epub 2012 Nov 5.
PubMed 23122189Casadevall A, Pirofski LA. The damage-response framework of microbial pathogenesis. Nat Rev Microbiol. 2003 Oct;1(1):17-24. doi: 10.1038/nrmicro732.
PubMed 15040176Menni C, Valdes AM, Freidin MB, Sudre CH, Nguyen LH, Drew DA, Ganesh S, Varsavsky T, Cardoso MJ, El-Sayed Moustafa JS, Visconti A, Hysi P, Bowyer RCE, Mangino M, Falchi M, Wolf J, Ourselin S, Chan AT, Steves CJ, Spector TD. Real-time tracking of self-reported symptoms to predict potential COVID-19. Nat Med. 2020 Jul;26(7):1037-1040. doi: 10.1038/s41591-020-0916-2. Epub 2020 May 11.
PubMed 32393804Yanes-Lane M, Winters N, Fregonese F, Bastos M, Perlman-Arrow S, Campbell JR, Menzies D. Proportion of asymptomatic infection among COVID-19 positive persons and their transmission potential: A systematic review and meta-analysis. PLoS One. 2020 Nov 3;15(11):e0241536. doi: 10.1371/journal.pone.0241536. eCollection 2020.
PubMed 33141862Watson J, Whiting PF, Brush JE. Interpreting a covid-19 test result. BMJ. 2020 May 12;369:m1808. doi: 10.1136/bmj.m1808. No abstract available.
PubMed 32398230Li X, Dunn J, Salins D, Zhou G, Zhou W, Schussler-Fiorenza Rose SM, Perelman D, Colbert E, Runge R, Rego S, Sonecha R, Datta S, McLaughlin T, Snyder MP. Digital Health: Tracking Physiomes and Activity Using Wearable Biosensors Reveals Useful Health-Related Information. PLoS Biol. 2017 Jan 12;15(1):e2001402. doi: 10.1371/journal.pbio.2001402. eCollection 2017 Jan.
PubMed 28081144Radin JM, Wineinger NE, Topol EJ, Steinhubl SR. Harnessing wearable device data to improve state-level real-time surveillance of influenza-like illness in the USA: a population-based study. Lancet Digit Health. 2020 Feb;2(2):e85-e93. doi: 10.1016/S2589-7500(19)30222-5. Epub 2020 Jan 16.
PubMed 33334565Emery JC, Russell TW, Liu Y, Hellewell J, Pearson CA; CMMID COVID-19 Working Group; Knight GM, Eggo RM, Kucharski AJ, Funk S, Flasche S, Houben RM. The contribution of asymptomatic SARS-CoV-2 infections to transmission on the Diamond Princess cruise ship. Elife. 2020 Aug 24;9:e58699. doi: 10.7554/eLife.58699.
PubMed 32831176Quer G, Radin JM, Gadaleta M, Baca-Motes K, Ariniello L, Ramos E, Kheterpal V, Topol EJ, Steinhubl SR. Wearable sensor data and self-reported symptoms for COVID-19 detection. Nat Med. 2021 Jan;27(1):73-77. doi: 10.1038/s41591-020-1123-x. Epub 2020 Oct 29.
PubMed 33122860Hadid A, McDonald EG, Cheng MP, Papenburg J, Libman M, Dixon PC, Jensen D. The WE SENSE study protocol: A controlled, longitudinal clinical trial on the use of wearable sensors for early detection and tracking of viral respiratory tract infections. Contemp Clin Trials. 2023 May;128:107103. doi: 10.1016/j.cct.2023.107103. Epub 2023 Mar 29.
PubMed 37147083
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Wearable Sensors for Early Detection and Tracking of Viral Respiratory Tract Infections: The WE SENSE Study
- ClinicalTrials.gov ID
- NCT05290792
- Acronym / sponsor ID
- WE SENSE / 2022-7591
- Conditions
- Viral Respiratory Tract Infection, Influenza
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Emily McDonaldUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Université de Montréal
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Viral respiratory tract infections (VRTI) are among the most common human illnesses, impacting billions globally. There is an unmet need to identify novel ways to detect, treat and prevent their spread. New wearable devices could address this need, using special biosensors worn by patients.
This is a single centre, controlled, before and after, longitudinal, clinical trial. Participants will receive FluMist, a live attenuated influenza vaccine, which will act as a proxy to a viral respiratory tract infection and create a very minor response to the immune system. Vital signs and activity levels will be monitored continuously using wearable biosensors for 7 days prior to and 7 days following, along with symptom tracking and blood tests to measure immune responses. Artificial intelligence (AI) and machine learning (ML) algorithms will be used to analyse the data.
AI and ML will identify subtle changes in vital signs and activity levels from the immune response to respiratory viruses. These data will help develop future methods to address important public health questions related to respiratory virus detection, containment and management.
The purpose of this study is to explore whether wearable sensors can detect, track the progress and recovery from viral respiratory tract infection.
Detailed description
Presently, there are no tools to continuously assess the objective body's response to respiratory viral infection in real time. An individual's inflammatory response to infection is primarily measured by the presence of symptoms. For example, reliance on the presence of fever as a sensitive sign of viral infection, while objective and measurable, can miss at least 50% of symptomatic cases of influenza illness. Fever is also not a sufficient sign of infection in studies of SARS-CoV-2. An additional technology to pair with the present contact tracing, test and contain strategy could become a critical public health mitigation strategy for VRTIs. Evidence suggests that use of wearable biosensor technology may enable researchers and healthcare professionals to detect inflammatory responses. Therefore, they could assist in medical diagnosis at the early phase of disease development - even before the onset of clinical symptoms.
In this study, the investigators aim to leverage FLUMIST, an intranasal Live Attenuated Influenza Vaccine (LAIV), to create a very minor response of the immune system. FLUMIST is one of the vaccines recommended by the National Advisory Committee on Immunization (NACI), among other vaccines for this flu season. It will be used as a test case, representing body's response to a minor viral infection (like those of 'common cold'). In addition, the associated changes in vital signs (for example, changes in heart rate), activity levels, symptoms and inflammatory/immune markers will be monitored. Subtle patterns of change might only be detectable using artificial intelligence (AI). Applying AI and machine learning (ML) to the wearables' data can allow for the future early detection of VRTI, along with continuous tracking of its progress, recovery or deterioration.
Study schedule:
Patient participation in this research project will last 2 weeks and will include 14 visits. Each visit will last up to 60 minutes. During this 14-day follow-up period, participants will be required to wear 3 vital signs monitoring systems (shirt, watch and a ring) and to report twice daily about their wellbeing/symptoms and about their alcohol/caffeine/drugs consumption.
Assessments:
-VRTI detection: To rule out asymptomatic VRTI during the baseline (pre-LAIV) period, a nasopharyngeal 21-multiplex polymerase chain reaction (PCR) test, which includes influenza, SARS-CoV-2 and other respiratory viruses, will be performed at screening. For those eligible participants that enter the study, baseline assessments will start the morning of Day -7 and be performed 7 days before inoculation (Days -7 to 0), which will occur the morning of Day 0.
-Symptom assessment: The following symptoms will be assessed through an app-based survey sent to participants twice daily during the 14-day observation period: nasal discharge; nasal obstruction; sneezing; headache; sore throat; malaise; muscle ache; cough; chilliness; decreased appetite; stomach ache; vomiting; diarrhea; shortness of breath; and wheeze. Symptom severity will be graded as 0 (absent) to 7 (severe).
-Wearable vital sign monitoring systems: Three wearable smart platforms will be used for continuous monitoring of physiologic and activity parameters using biosensors: Oura ring (Oura Oy, Finland); Biobeat watch (Biobeat technologies LTD, Israel); and Astroskin shirt (by Hexoskin, Canada).
-Inflammatory cytokines and biomarkers: A venous blood sample for measurement of inflammatory cytokines and biomarkers will be obtained by a healthcare professional once in the morning of Day -7 (baseline sample 1) and then twice daily starting Day 0, with baseline sample #2 collected prior to inoculation on Day 0.
-Physiological response assessment: Participants will complete five, 3-minute constant-rate stair stepping tests (3-min CRSST). The 3-min CRSST requires participants to step up and down a 20cm step to the pace of a constant external audio beep. Participants will complete all trials at a 30 steps/min stepping rate. Cardiac and respiratory parameters will be collected at rest and during each 3-min CRSST using the wearable devices.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single centre, controlled, before and after, longitudinal, intra-individual assessment
| Arm | Type | Receives |
|---|---|---|
| Intra-individual changes of physiological and activity parameters | Other | Biological: Administration of FluMist (Live Attenuated Influenza Vaccine)Participants will be administered FluMist (live attenuated influenza vaccine) to induce a low grade VRTI (Day 0). Participants will be monitored in the 7 days prior and 7 days after vaccination via symptom questionnaires, blood draws, stair tests and vital sign monitoring from wearable sensors. Each participant will serve as their own control, relying on the baseline measurements obtained over the 7-day period prior to inoculation. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men or women aged 18-59 years
- Did not receive the 2021-2022 seasonal influenza vaccine
- Not planning to get another vaccine during the 14-day observation period.
Key exclusion criteria (13 listed)
- PCR-confirmed VRTI at screening
- Any infectious symptoms (fever, cough, rhinorrhea, sore throat, diarrhea, loss of smell or taste) within the previous 7 days
- Any chronic medical condition;
- Obesity (BMI>35 kg/m2);
- Any prescription drug other than oral contraceptives or routine and stable dose medications;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of FluMist (Live Attenuated Influenza Vaccine)Participants will received the intranasal FluMist vaccine that will serve as a proxy for a viral respiratory tract infection and trigger a mild immune response. | Biological | Intra-individual changes of physiological and activity parameters |
Primary outcome
Changes in heart rate (in beats per minute)
Time frame: 14 days
Intra-individual changes in heart rate before and after receipt of the Live Attenuated Influenza Vaccine measured by wearable sensors.
Changes in heart rate variability (in milliseconds)
Time frame: 14 days
Intra-individual changes in heart rate variability before and after receipt of the Live Attenuated Influenza Vaccine measured by wearable sensors.
Changes in respiratory rate (in breaths per minute)
Time frame: 14 days
Intra-individual changes in respiratory rate before and after receipt of the Live Attenuated Influenza Vaccine measured by wearable sensors.
Changes in skin temperature (in degrees Celsius)
Time frame: 14 days
Intra-individual changes in skin temperature before and after receipt of the Live Attenuated Influenza Vaccine measured by wearable sensors.
Changes in acceleration (meters/second^2)
Time frame: 14 days
Intra-individual changes in acceleration before and after receipt of the Live Attenuated Influenza Vaccine measured by wearable sensors.
Changes in blood pressure (in mmHg)
Time frame: 14 days
Intra-individual changes in blood pressure before and after receipt of the Live Attenuated Influenza Vaccine measured by wearable sensors.
Changes in oxygen saturation (SpO2 in %)
Time frame: 14 days
Intra-individual changes in oxygen saturation before and after receipt of the Live Attenuated Influenza Vaccine measured by wearable sensors.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Background: PubMed 17544181Molinari NA, Ortega-Sanchez IR, Messonnier ML, Thompson WW, Wortley PM, Weintraub E, Bridges CB. The annual impact of seasonal influenza in the US: measuring disease burden and costs. Vaccine. 2007 Jun 28;25(27):5086-96. doi: 10.1016/j.vaccine.2007.03.046. Epub 2007 Apr 20.
- Background: PubMed 23122189Schanzer DL, McGeer A, Morris K. Statistical estimates of respiratory admissions attributable to seasonal and pandemic influenza for Canada. Influenza Other Respir Viruses. 2013 Sep;7(5):799-808. doi: 10.1111/irv.12011. Epub 2012 Nov 5.
- Background: PubMed 15040176Casadevall A, Pirofski LA. The damage-response framework of microbial pathogenesis. Nat Rev Microbiol. 2003 Oct;1(1):17-24. doi: 10.1038/nrmicro732.
- Background: PubMed 32393804Menni C, Valdes AM, Freidin MB, Sudre CH, Nguyen LH, Drew DA, Ganesh S, Varsavsky T, Cardoso MJ, El-Sayed Moustafa JS, Visconti A, Hysi P, Bowyer RCE, Mangino M, Falchi M, Wolf J, Ourselin S, Chan AT, Steves CJ, Spector TD. Real-time tracking of self-reported symptoms to predict potential COVID-19. Nat Med. 2020 Jul;26(7):1037-1040. doi: 10.1038/s41591-020-0916-2. Epub 2020 May 11.
- Background: PubMed 33141862Yanes-Lane M, Winters N, Fregonese F, Bastos M, Perlman-Arrow S, Campbell JR, Menzies D. Proportion of asymptomatic infection among COVID-19 positive persons and their transmission potential: A systematic review and meta-analysis. PLoS One. 2020 Nov 3;15(11):e0241536. doi: 10.1371/journal.pone.0241536. eCollection 2020.
- Background: PubMed 32398230Watson J, Whiting PF, Brush JE. Interpreting a covid-19 test result. BMJ. 2020 May 12;369:m1808. doi: 10.1136/bmj.m1808. No abstract available.
- Background: PubMed 28081144Li X, Dunn J, Salins D, Zhou G, Zhou W, Schussler-Fiorenza Rose SM, Perelman D, Colbert E, Runge R, Rego S, Sonecha R, Datta S, McLaughlin T, Snyder MP. Digital Health: Tracking Physiomes and Activity Using Wearable Biosensors Reveals Useful Health-Related Information. PLoS Biol. 2017 Jan 12;15(1):e2001402. doi: 10.1371/journal.pbio.2001402. eCollection 2017 Jan.
- Background: PubMed 33334565Radin JM, Wineinger NE, Topol EJ, Steinhubl SR. Harnessing wearable device data to improve state-level real-time surveillance of influenza-like illness in the USA: a population-based study. Lancet Digit Health. 2020 Feb;2(2):e85-e93. doi: 10.1016/S2589-7500(19)30222-5. Epub 2020 Jan 16.
- Background: PubMed 32831176Emery JC, Russell TW, Liu Y, Hellewell J, Pearson CA; CMMID COVID-19 Working Group; Knight GM, Eggo RM, Kucharski AJ, Funk S, Flasche S, Houben RM. The contribution of asymptomatic SARS-CoV-2 infections to transmission on the Diamond Princess cruise ship. Elife. 2020 Aug 24;9:e58699. doi: 10.7554/eLife.58699.
- Background: PubMed 33122860Quer G, Radin JM, Gadaleta M, Baca-Motes K, Ariniello L, Ramos E, Kheterpal V, Topol EJ, Steinhubl SR. Wearable sensor data and self-reported symptoms for COVID-19 detection. Nat Med. 2021 Jan;27(1):73-77. doi: 10.1038/s41591-020-1123-x. Epub 2020 Oct 29.
- Derived from this study: PubMed 37147083Hadid A, McDonald EG, Cheng MP, Papenburg J, Libman M, Dixon PC, Jensen D. The WE SENSE study protocol: A controlled, longitudinal clinical trial on the use of wearable sensors for early detection and tracking of viral respiratory tract infections. Contemp Clin Trials. 2023 May;128:107103. doi: 10.1016/j.cct.2023.107103. Epub 2023 Mar 29.
- Individual participant dataSharing planned: No. Deidentified data and code may be available for educational or research purposes upon reasonable request to the Principal Investigator, Dr. Dennis Jensen (dennis.jensen@mcgill.ca), subject to inter-institutional data sharing agreements
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily G McDonald, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Dennis Jensen, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of FluMist (Live Attenuated Influenza Vaccine) in people with Viral Respiratory Tract Infection and Influenza, run by Emily McDonald at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in heart rate (in beats per minute) (time frame: 14 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05290792, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.